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Results For "European-Union"

187 News Found

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses


Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer
Drug Approval | September 23, 2022

Lynparza approved in China as first-line maintenance treatment with Bevacizumab for HRD- positive advanced ovarian cancer

One in two women with advanced ovarian cancer has an HRD-positive tumor


Charsire's new drug aims to capture dementia treatment market
Biotech | September 22, 2022

Charsire's new drug aims to capture dementia treatment market

Charsire Biotechnology Corp. has successfully developed a revolutionary new drug (BAC) for Alzheimer's disease


BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin
Drug Approval | September 22, 2022

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.


Tezspire approved in the EU for the treatment of severe asthma
Drug Approval | September 21, 2022

Tezspire approved in the EU for the treatment of severe asthma

First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations


Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
Drug Approval | September 21, 2022

Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19

Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial


Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA
Diagnostic Center | September 12, 2022

Merck and Eisai present results from Phase 3 LEAP-002 Trial evaluating KEYTRUDA

Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU
News | September 05, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise


Bayer showcases cancer study data at ESMO Congress 2022
News | September 01, 2022

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors